Recalls / Class I
Class ID-0971-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
- Affected lot / code info
- UPC 859613252258
Why it was recalled
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Recalling firm
- Firm
- Novacare, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 312 W 6100 S, N/A, Murray, Utah 84107-6990
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-08-24
- FDA classified
- 2016-06-06
- Posted by FDA
- 2016-06-15
- Terminated
- 2017-08-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0971-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.